Glulisine + Lantus in Type I Patients
Phase 3
Completed
- Conditions
- Diabetes Mellitus, Type 1
- Registration Number
- NCT00545337
- Lead Sponsor
- Sanofi
- Brief Summary
To evaluate the efficacy (in terms of change HbA1c from baseline to endpoint) and safety (in terms of adverse events, clinical chemistry, lipids, hematology) of insulin glulisine (HMR 1964) in subjects with type I diabetes mellitus
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
- type I diabetes mellitus (onset of diabetes under the age of 40),
- an HbA1c range of >6.5 - <11%,
- and on multiple injection regimen (more than 1 year of continuous insulin treatment),
- body mass index <35.
Exclusion Criteria
- Active proliferative diabetic retinopathy,
- Diabetes other than type I diabetes mellitus,
- Pancreatectomised subjects,
- Subjects who have undergone pancreas and or islet cell transplants,
- Requiring treatment with not permited drugs during the study,
- Previous treatment (in the period not less than 1 month before the beginning of the trial) with insulin glargine,
- Hypersensitivity to insulin,
- Major systemic diseases,
- Impaired hepatic or renal function
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Change of HbA1c from baseline to endpoint
- Secondary Outcome Measures
Name Time Method Change of HbA1c from baseline to week 26 Blood glucose parameters, hypoglycemic episodes and dosage of the mealtime and basal insulins from baseline to endpoint
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie insulin glulisine's efficacy in Type 1 diabetes compared to other rapid-acting insulins?
How does the combination of insulin glulisine and glargine compare to standard basal-bolus regimens in Type 1 diabetes for HbA1c reduction?
What biomarkers correlate with improved glycemic control in NCT00545337's Type 1 diabetes cohort using glulisine and Lantus?
What adverse event profiles are associated with insulin glulisine in Type 1 diabetes, and how do they compare to lispro or aspart?
How does Sanofi's glulisine-glargine regimen compare to Novo Nordisk's or Eli Lilly's rapid-basal insulin combinations in Type 1 diabetes management?
Trial Locations
- Locations (1)
Sanofi-Aventis
🇺🇦Kiev, Ukraine